EP2396067B2 - Perkutaner führungsdraht - Google Patents

Perkutaner führungsdraht Download PDF

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Publication number
EP2396067B2
EP2396067B2 EP10703669.1A EP10703669A EP2396067B2 EP 2396067 B2 EP2396067 B2 EP 2396067B2 EP 10703669 A EP10703669 A EP 10703669A EP 2396067 B2 EP2396067 B2 EP 2396067B2
Authority
EP
European Patent Office
Prior art keywords
guidewire
end portion
distal end
tip
radius
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP10703669.1A
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English (en)
French (fr)
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EP2396067A1 (de
EP2396067B1 (de
Inventor
Stephen BRECKER
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Medtronic CV Luxembourg SARL
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Medtronic CV Luxembourg SARL
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Application filed by Medtronic CV Luxembourg SARL filed Critical Medtronic CV Luxembourg SARL
Publication of EP2396067A1 publication Critical patent/EP2396067A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09016—Guide wires with mandrils
    • A61M25/09025—Guide wires with mandrils with sliding mandrils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/0915—Guide wires having features for changing the stiffness

Definitions

  • the present invention relates to percutaneous guidewires.
  • Guidewires in accordance with embodiments of the present invention have particular, although not necessarily exclusive, application in the percutaneous delivery of replacement heart valves.
  • Percutaneous guidewires are commonly used in gastrointestinal, hepatobiliary and cardiac procedures. They are introduced percutaneously and manipulated through a vessel to the site of interest, using fluoroscopy, for example, to monitor the path taken by the guidewire. They are usually the first medical device that will reach the site of interest. Once in place, they can subsequently be used to reliably guide catheters, endoscopes and other delivery systems to the site of interest, by passing these delivery systems over the guidewire.
  • percutaneous guidewires must operate tend to place conflicting constraints on their design.
  • the guidewire must typically have sufficient stiffness to enable a physician to pass them along the vessel they are introduced through, as well as to accurately guide the delivery systems that they are subsequently employed to deliver.
  • they need to be flexible enough to follow the sometimes tortuous paths they must follow through the vasculature to reach the site of interest.
  • An overly stiff guidewire also increases the risk of the tip of the guidewire puncturing the wall a vessel wall or other tissue it encounters,
  • guidewires have a composite construction consisting of a solid metal core (1) and outer metal coil (3) terminating at a rounded, atraumatic tip (4), as illustrated schematically in Fig. 1 .
  • the inner core tends to be ground or drawn so that its diameter reduces towards to the tip of the guidewire. This reduces the stiffness of the distal end portion of the guidewire to reduce the risk of the wire end puncturing soft tissue.
  • a majority of guidewires are supplied straight, although many are provided with a tip portion that can be manually bent into a desired shape by the user, for example to aid in navigating a tortuous path.
  • the user may bend the end of the wire to help minimise the likelihood that the wire end causes trauma if it impinges on soft tissue; on impact, force is transmitted radially rather than longitudinally along the wire.
  • guidewires with a pre-formed curve at their distal end portion (2), as seen schematically in figs. 2a and 2b .
  • the curved form of the end of these so called 'J-tip' guidewires further reduces the likelihood of trauma if the end of the wire impacts soft tissue as it is being advanced.
  • PHV percutaneous heart valve
  • the wire in order to successfully place the artificial valve the wire must be stiff enough at the aortic valve to sufficiently support the delivery system.
  • the tip must be atraumatic enough to prevent damaging the thin ventricular wall should it come into contact during the pushing and pulling of the valve delivery.
  • the guide wire may, however, have a user imparted bend to help it conform to the V shape of the ventricle (as shown in fig. 3a ). Even then there is still a high risk, especially if the user has imparted a bend to the wire with a small radius of curvature, that if the wire contacts the ventricular wall it will kink and potentially cause traumatic injury (see fig. 3b ).
  • WO 2004/018031 describes a guide wire.
  • EP 0 778 043 describes a guide wire unit with internal guide wire of shape memory alloy.
  • Such guidewires may be useful, for instance, for PHV placement and other procedures in which the distal end of the guidewire might inadvertently contact a very thin tissue wall, such as the ventricular wall.
  • the present invention provides a percutaneous guidewire comprising a distal end portion that is pre-formed in a curve that turns through more than 270 degrees. Preferably the curve turns through at least one complete revolution, i.e. at least 360 degrees.
  • the long curve helps to prevent any part of the wire causing trauma to soft tissues as very little force can be longitudinally transmitted to the tip.
  • the looping curve also provides for a longer transition between the stiff support section of the wire and soft atraumatic tip in the case where the stiffness of the wire decreases towards the tip, as is preferred.
  • the distal end portion of the guidewire may be resiliently deformable so that if it is deformed either during delivery or in use, it resumes its pre-formed curved shape once the external force is removed. That is to say, the pre-formed curvature is that shape that the wire adopts in a relaxed state.
  • the stiffness of the guidewire decreases along the length of the curved distal end portion towards the tip of the guidewire.
  • the transition from the stiffer, straight proximal portion of the guidewire towards the tip at the distal end is preferably a smooth transition with no steps, providing a continuous decrease in stiffness along the distal end portion of the wire towards its tip.
  • the wire is preferably configured so that the stiffness starts to decrease in the straight portion of the wire and then continues to decrease along the length of the curved portion.
  • the rate at which the stiffness of the guidewire decreases along the length of the curve may be linear. Alternatively it may be proportional to the (preferably decreasing) radius of curvature.
  • the change in stiffness can be achieved through a reduction in the diameter of the wire core towards the tip.
  • the tapering of the wire may start on the straight portion of the wire (preferably close to but not at the start of the curved portion) and continue over the transition from the straight portion of the wire to the curved portion, and along the length of the curved portion to the tip.
  • the outer spiral winding may be of constant diameter.
  • the radius of curvature of the curved distal end portion may decrease towards the tip of the guidewire.
  • the rate of change of the radius of curvature is typically non-linear, with the rate of change decreasing towards the tip. This allows for multiple loops within one another, making it even less likely that the tip of the wire can cause trauma, whilst minimising the space occupied by the end portion of the guidewire.
  • the curvature of the distal end portion may, for example, be a logarithmic spiral or, starting from the tip, the radius of curvature of the distal end portion may increase for every 90 degrees of curvature according to a Fibonacci sequence. Other non-linear changes in radius are also possible.
  • the maximum radius of the curved distal end portion is preferably 3.5 cm or less.
  • the various embodiments of the invention described below provide atraumatic guidewires that are particularly suitable for use in percutaneous heart valve (PHV) delivery.
  • the guidewires have resiliently deformable distal end portions that are pre-formed, e.g. during manufacture, to have a curved geometry that is designed to minimise the risk of trauma in the event that the tip portion contacts the ventricular wall as the PHV is being manipulated into position using the guidewire.
  • FIG. 4 shows a guidewire in accordance with one embodiment of the invention.
  • the guidewire comprises a solid metal core wire (13) that is surrounded by an outer casing (14).
  • the outer casing may, for example, be a spirally wound metal casing, as in known composite guidewires.
  • the tip of the guide wire is also fitted with a bulbous atraumatic tip (4).
  • the core and casing of the guidewire may be constructed from materials that are conventionally used for percutaneous guidewires, including, for example, stainless steel and/or metal alloys such as nitinol (a nickel-titanium alloy).
  • the outer casing may be formed as a polymer coating.
  • the outer surface of the coating is preferably formed of a hydrophilic material.
  • Known hydrophilic polymers may be used, either to form the complete polymer coating or as a surface coating on another polymer that forms the main outer casing.
  • the coating may be applied only to the distal 2/3 or less or even to the distal 1/3 or less of the guidewire. This helps to ensure that the physician can maintain a good grip on the guidewire even when wearing wet gloves.
  • a main portion (11) of the guidewire is straight but, in accordance with present invention, a distal end portion (15) of the guidewire is pre-formed in a curve, which in this example turns through about 540 degrees.
  • the tip (4) of the guidewire sits within the looped end portion (15) significantly reducing the likelihood that it will make contact with the ventricular wall. Rather, in the event that the end portion of the guidewire is thrust into contact with the ventricular wall, it will most likely be a relatively gently curved part of the guidewire that makes contact and resiliently deforms greatly reducing the chances of any trauma.
  • the core wire (13) tapers gradually along the length of the curved end portion (15) from the transition between straight and curved portions to the tip of the guidewire.
  • the taper may commence proximally of the transition between straight and curved portions (e.g. at or near the point labelled 'A' in fig. 5 ). In this way, as the taper commences on the straight portion, rather than at the transition, if there is a step at the outset of the taper, this step will not be at the start of the curvature (the most likely place for a kink to form).
  • the reduction in diameter of the core wire means that the stiffness of the core, and hence the overall guidewire, decreases towards the tip. This decreased stiffness makes the wire less traumatic, compensating at least to some degree (and preferably substantially entirely) for the greater trauma that might otherwise result from the parts of the guidewire end portion having a smaller radius of curvature.
  • Fig. 5 shows the guidewire of figure 4 after it has been introduced into the left ventricle (7) of the patient's heart (6).
  • the transition between the straight portion (11) of the guidewire and the curved end portion (15) is preferably gradual and has no steps, as seen for example in fig. 6 .
  • the radius of curvature at the transition is relatively large. It would be undesirable however, and in fact impractical, to maintain such a large radius of curvature along the length of the curved end portion because the overall effective area of this portion would become too large to be accommodated in the ventricle; typically the maximum diameter of the curved portion should be no more than 3.5cm. To cater for patients with a smaller than average ventricle, a maximum diameter of 2.5cm may be desirable. Generally, however, to avoid to tight a spiral, that might lead to trauma, the maximum diameter is at least 1 cm.
  • the radius of curvature decreases significantly towards the tip of the guidewire, so that the curved portion spirals inwardly.
  • the radius of the curved portion (15) increases, as one moves away from the tip (4), with a logarithmic spiral. This means that at the transition point (18) between the straight portion of the guide wire (11) and the curved section (15), there is not a sharp transition and therefore the likelihood of a kink at this point (18) is lowered.
  • Figs. 7a and 7b illustrate another embodiment of the invention, wherein the radius of the curved section (15) increases, as one moves away from the tip (4).
  • core (17) of the guide wire (16) is formed from a metal wire, the diameter of which tapers towards a point at the bulbous atraumatic tip (4).
  • the core wire (16) is coated in a flexible polymer (19) that is itself hydrophilic or has a hydrophilic coating.
  • Figure 8 shows a comparison of the effective area of a circular loop (20), and the reduced area (21) occupied by a Fibonacci spiral in a guide wire (16) as shown in figures 7a and 7b . It can be seen that the Fibonacci spiral occupies an area that is reduced by about 2.4 times compared with the circular loop.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Claims (12)

  1. Perkutaner Führungsdraht, umfassend einen distalen Endabschnitt (15), der in einer Kurve vorgeformt ist, die eine Wendung von mehr als 270 Grad vollzieht, wobei die Kurve einen Krümmungsradius aufweist, der zur Spitze (4) des Führungsdrahts hin abnimmt,
    wobei die Steifigkeit des Führungsdrahts entlang der Länge des gekrümmten distalen Endabschnitts (15) zur Spitze (4) des Führungsdrahts hin zunimmt,
    wobei die Änderung der Steifigkeit entlang der Länge des gekrümmten distalen Endabschnitts (15) kontinuierlich ist, dadurch gekennzeichnet, dass
    die Abnahme der Steifigkeit des Führungsdrahts an einem geraden Abschnitt (11) des Führungsdrahts proximal zu einem Übergang des Führungsdrahts von einem geraden Abschnitt (11) zum gekrümmten Abschnitt beginnt.
  2. Führungsdraht nach Anspruch 1, wobei die vorgeformte Kurve eine Wendung von wenigstens 360 Grad vollzieht, vorzugsweise 450 Grad und mehr bevorzugt wenigstens 540 Grad.
  3. Führungsdraht nach einem der vorangehenden Ansprüche, wobei der distale Endabschnitt (15) des Führungsdrahts elastisch verformbar ist.
  4. Führungsdraht nach einem der Ansprüche 1 bis 3, wobei der Grad, mit dem die Steifigkeit des Führungsdrahts entlang der Länge der Kurve abnimmt:
    (a) proportional zum Krümmungsradius ist; oder
    (b) linear ist.
  5. Führungsdraht nach einem der Ansprüche 1 bis 6, umfassend einen inneren Kerndraht (13) mit einer äußeren Wicklung, und wobei die Änderung der Steifigkeit sich aus einer Änderung des Durchmessers des Kerndrahts (13) ergibt.
  6. Führungsdraht nach einem der Ansprüche 1 bis 5, wobei der Änderungsgrad des Krümmungsradius nichtlinear ist.
  7. Führungsdraht nach einem der vorangehenden Ansprüche, wobei der maximale Radius des gekrümmten distalen Endabschnitts (15) 3,5 cm oder weniger beträgt.
  8. Führungsdraht nach Anspruch 7, wobei der maximale Radius des gekrümmten distalen Endabschnitts (15) 2,5 cm oder weniger beträgt.
  9. Führungsdraht nach einem der vorangehenden Ansprüche, wobei der maximale Radius des gekrümmten distalen Endabschnitts (15) 1 cm oder mehr beträgt.
  10. Führungsdraht nach einem der vorangehenden Ansprüche, umfassend einen inneren Kerndraht (13, 17) mit einem Außenmantel; wobei der Außenmantel:
    (a) eine Metallwicklung ist, oder
    (b) eine Polymerbeschichtung ist.
  11. Führungsdraht nach Anspruch 10, wobei wenigstens ein Abschnitt einer Außenfläche der Polymerbeschichtung hydrophil ist; und wobei ein proximaler Endabschnitt des Führungsabschnitts keine hydrophile Beschichtung aufweist.
  12. Führungsdraht nach einem der vorangehenden Ansprüche, umfassend eine gerundete atraumatische Spitze (4).
EP10703669.1A 2009-02-12 2010-02-12 Perkutaner führungsdraht Active EP2396067B2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0902339.1A GB0902339D0 (en) 2009-02-12 2009-02-12 Percutaneous guidewire
PCT/GB2010/000251 WO2010092347A1 (en) 2009-02-12 2010-02-12 Percutaneous guidewire

Publications (3)

Publication Number Publication Date
EP2396067A1 EP2396067A1 (de) 2011-12-21
EP2396067B1 EP2396067B1 (de) 2016-02-10
EP2396067B2 true EP2396067B2 (de) 2023-03-01

Family

ID=40548090

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10703669.1A Active EP2396067B2 (de) 2009-02-12 2010-02-12 Perkutaner führungsdraht

Country Status (4)

Country Link
US (1) US9968761B2 (de)
EP (1) EP2396067B2 (de)
GB (1) GB0902339D0 (de)
WO (1) WO2010092347A1 (de)

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WO2010092347A1 (en) 2010-08-19
GB0902339D0 (en) 2009-04-01
US20120016342A1 (en) 2012-01-19
EP2396067A1 (de) 2011-12-21
US9968761B2 (en) 2018-05-15
EP2396067B1 (de) 2016-02-10

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